Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia
Phase 2
Completed
NCT02477670
| Condition | Schizophrenia |
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| Phase | Phase 2 |
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| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| Status | Completed |
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| Enrollment | 145 participants |
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| Interventions | AVP-786 |
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| Start date | Sep 1, 2015 |
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| Completion date | Jul 21, 2017 |
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| Results posted | Sep 16, 2020 |
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Summary
The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability of AVP-786 as an adjunctive treatment compared with placebo in patients with residual schizophrenia.
Change From Baseline in the 16-Item Negative Symptom Assessment (NSA-16) Total Score at Week 6 and Week 12
Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2) · score on a scale
| Stage 1: AVP-786 | 61.0 ± 7.53 score on a scale |
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| Stage 1: Placebo | 60.4 ± 7.71 score on a scale |
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| Stage 1: AVP-786 | -5.0 ± 5.64 score on a scale |
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| Stage 1: Placebo | -3.4 ± 5.54 score on a scale |
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| Stage 1 Placebo Non-responders; Stage 2: Placebo | 57.6 ± 9.39 score on a scale |
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| Stage 1 Placebo Non-responders; Stage 2: AVP-786 | 57.6 ± 9.09 score on a scale |
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| p-value | 0.073 |
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| SPCD Weighted OLS z-statistic | -1.79 (95% CI -3.75–0.17) |
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Open in BENITIONS
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